BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAS FIX PIN 3.2D X 150MM STR

    MDR report key: 12750649 · Received November 4, 2021

    Report

    Report Number
    0009617840-2021-00024
    Event Type
    Injury
    Date Received
    November 4, 2021
    Date of Event
    October 11, 2021
    Report Date
    April 8, 2022
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    K182964
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). G2 - JAPAN. THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION FROM THE COMPLETED INVESTIGATION. EVALUATION SUMMARY: LOGS FILES ASSOCIATED TO REPORTED EVENT WERE NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION ON THE REPORTED EVENT WAS MADE AVAILABLE AFTER MULTIPLE FOLLOW UP ATTEMPTS WITH THE CONTACT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE MOMENT AS REPORTED EVENT COMPLAINT CANNOT BE CONFIRMED WITHOUT TECHNICAL EVALUATION OR LOGS ANALYSIS. DHR REVIEW: DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW BY PART NUMBER ¿20-8000-000¿ AND ¿208000000¿. A COMPLAINT HISTORY REVIEW BY SERIAL NUMBER WAS NOT CONDUCTED AS THE SERIAL NUMBER WAS NOT MADE AVAILABLE. THE SEARCH IDENTIFIED NO) ADDITIONAL COMPLAINTS REPORTED FOR PART NUMBER ¿20-8000-000-XX¿ WITHIN ONE (1) YEAR PRIOR TO THE NOTIFICATION DATE OF THIS COMPLAINT ((B)(6), 2021) AND THEREAFTER FOR THE SAME OR SIMILAR ISSUE. ROOT CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY A FIXATION PIN WAS INSERTED TOO DEEPLY DAMAGING THE PATIENT'S ARTERY. THE BLEEDING WAS STOPPED INTRAOPERATIVELY AND THE PATIENT CONTINUED TO BE MONITORED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY A FIXATION PIN WAS INSERTED TOO DEEPLY DAMAGING THE PATIENT'S ARTERY. THE BLEEDING WAS STOPPED INTRAOPERATIVELY AND THE PATIENT CONTINUED TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1652341 CAS FIX PIN 3.2D X 150MM STR ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention